The Health Sciences Authority (HSA) of Singapore has provisionally authorised Breathonix’s BreFence Go COVID-19 Breath Test System for accurate disease identification in a minute.
The test is said to be the first-of-its-kind to obtain provisional authorisation in the country.
A spin-off firm from the National University of Singapore (NUS), Breathonix developed the breath test system to identify volatile organic compounds (VOCs) in an individual’s exhaled breath.
VOCs are generated by several biochemical reactions in human cells. As the VOCs signature of a healthy individual’s breath differs from an ill person, the VOCs changes are considered markers for diseases such as Covid-19.
To conduct the BreFence test, the user must blow into a disposable one-way valve mouthpiece attached to a breath sampler.
For VOCs measurement, the exhaled breath is fed into a mass spectrometer. Subsequently, a software algorithm assesses the VOCs biomarkers and delivers results within one minute.
The simple test can be performed by a trained person but does not need medically trained personnel or processing in the laboratory.
A positive result with the breath test will require a polymerase chain reaction (PCR) Covid-19 swab test for confirmation.
Breathonix CEO Dr Jia said: “Our breath test is non-invasive. Users only need to breathe out normally into the disposable mouthpiece provided, so there will not be any discomfort.
“Cross-contamination is unlikely as the disposable mouthpiece has a one-way valve and a saliva trap to prevent inhalation or saliva from entering the machine.”
Clinical trials of the breath test were carried out at three locations from June last year to April this year.
Trials in Singapore were conducted at the National Centre for Infectious Diseases and Changi Airport.
A third trial was conducted in Dubai, in partnership with the Dubai Health Authority (DHA) and the Mohammed Bin Rashid University of Medicine and Health Sciences.
The Dubai trial enrolled 2,500 subjects at DHA’s Nadd Al Hamar primary health care centre.
According to data from a pilot study carried out in Singapore on 180 subjects, the BreFence Go COVID-19 Breath Test System was found to have 93% sensitivity and 95% specificity with a machine learning algorithm.
Currently, Breathonix, along with the Singapore Ministry of Health (MOH), plans to conduct a deployment trial at Tuas Checkpoint where travellers entering the country will be screened with the breath test system.